QWR · Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Microbiology · 21 CFR 866.3982 · Class 2
Overview
| Product Code | QWR |
|---|---|
| Device Name | Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings |
| Regulation | 21 CFR 866.3982 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from symptomatic individuals. It is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests.
Classification Rationale
Class II (special controls). The device is a simple qualitative device to directly detect SARS-CoV-2 virus targets in human clinical specimens for settings operating under a certificate of waiver or at home use.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. | Apr 11, 2025 | SESE |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Dec 4, 2023 | SESE |
| K221925 | ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | Aug 10, 2023 | SESE |
Top Applicants
- Roche Molecular Systems, Inc. — 2 clearances
- Abbott Diagnostics Scarborough, Inc. — 1 clearance
